FDA names drugmakers potentially acting to delay cheap generics

FDA names drugmakers potentially acting to delay cheap generics

Reutersreports that the U.S. Food and Drug Administration (FDA) listed a number of pharmaceutical companies that it believes could be “blocking access to their medicines in order to delay generic competition.” Author Michael Erman reports that:

The agency said companies on the list may be using FDA safety regulations and other tactics to deny access to their medicines from generic drugmakers hoping to copy them.

Specifically, the generic makers need access to samples which the brands may be intentionally withholding. FDA Commission Scott Gottlieb affirmed the agency’s commitment to make “faster approvals of cheaper generic medicines a priority” and indicated the agency is “notifying the Federal Trade Commission, which can investigate anti-competitive acts, of cases where drugmakers may be blocking access to their products if there is no safety reason.”

Why are the medical device reprocessors taking notice? Like the brand name drugmakers, some original equipment manufacturers have engaged in aggressive anti-reprocessing tactics which have the effect of driving up sales (and healthcare costs). By reprocessing medical devices, hospitals are able to maximize the value of their existing medical technology and thereby reduce procedural costs and waste.

Hospitals, and therefore patients, end up paying more when some manufacturers insert chips, upgrade software or engage in other means to “force obsolescence.” By shortening the technology lifecycles of their products, and rolling these products out as “new and improved,” as discussed by Tom Finn in Spend Matters, the result is greater profits for the device companies but higher costs for everyone else:

If you’re not familiar with the Stockholm syndrome procurement context, the implication here is that hospital purchasing staffers tend to identify with the goals and objectives of their “captors.” In this case, the captors are the major pharmaceutical and device manufacturers (OEMs). Of course, the problem is, they’re doing so at their own expense. And while the acute care market is not alone in providing a high-powered example of an industry dominated by its largest suppliers, this is a particularly painful one, given how plainly unsustainable healthcare’s current economics are.

AMDR is going to be watching FDA’s efforts to crack down on brand drugmaker efforts to drive down generic competition. We’ve seen it in the device side and are eager to show policy makers and those in the healthcare supply chain how promoting reprocessing, increases quality, reduces costs and improves patient care.